Description

To help improve customer satisfaction, greater emphasis is given to the aspect of quality in the supply chain. This webinar will help you understand some of the quality issues and methodologies that are relevant in current supply chain management.

Why Should You Attend?

The supply chain of the pharmaceutical industry is similar to that of any other industry in the manufacturing sector. However, in the US, the pharmaceutical industry has only two drug distribution channels: prescription and OTC (over-the-counter). The US Food and Drug Administration regulates both of these channels.
Because pharmaceuticals directly affect millions of people’s health, industry manufacturers are very strict about ensuring the safety and quality of drugs at each level of the supply chain. These companies use fixed, regulator-certified suppliers of raw materials. Companies also store the raw and packaging materials in separate warehouses.
After a company processes the raw materials, it makes the final drug at the manufacturing unit. A company that has a single manufacturing unit uses only one warehouse, while a company with multiple manufacturing units stores its drugs in central and regional warehouse

Areas Covered

-- What is a supply chain?
-- Examples of basic supply chain
-- Supply Chain Management Factors
-- How to handle external suppliers
-- Third Party Audits
-- Logistics and Distribution
-- The role of the Warehouse
-- Quality Management

Who will Benefit

Industries who can attend

This 60-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel

Speaker Profile

Danielle DeLucy, MS, is currently an independent consultant to the biologics and pharmaceutical industries specializing in the areas of quality assurance and quality systems. Prior to this role, Ms. DeLucy has been in the industry for 15 years serving in numerous quality management roles, such as the director of product quality, the oversight of sterility assurance practices and provided QA oversight of numerous filling and packaging operations.

Ms. DeLucy began her QA career as a quality control pharmaceutical microbiologist at Lancaster Laboratories, a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the quality management arena while increasing her responsibility. She has helped lead many regulatory health inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, she assists companies who are faced with warning letters and consent decrees establish more robust quality systems so that the company can succeed.